Moderna Spikevax COVID-19 Vaccine

 All COVID-19 vaccines authorized in Canada are safe, effective, and of high quality.

Name: Spikevax® Vaccine from Moderna against COVID-19

Manufacturer ModernaTX, Inc.

Type: mRNA

Status: Approved by Health Canada

Approved for: people 12 years of age and older

Method of administration: Injection into a muscle (usually the upper arm)

Number of doses: 2 doses

People for whom the vaccine is approved

The vaccine is approved for people 12 years of age and older. Its safety and efficacy in young people under 12 years of age have not yet been demonstrated.

Efficiency

Clinical trials showed that from two weeks after the second dose, Moderna's Spikevax® COVID-19 vaccine was 94.1% effective in protecting clinical trial participants from COVID-19.

Dosage

Two doses are required for maximum protection.

The dosage schedule approved by Health Canada calls for 2 doses at one-month intervals, based on evidence from clinical trials.

A booster dose of the Moderna COVID-19 Spikevax® vaccine may be given to people 18 years of age and older at least six months after completing their primary vaccine series.

Your province or territory decides when doses are administered.

These decisions are based on public health recommendations and the most recent data.

Mixed dose schedules

A different vaccine may be offered for your second dose. For example, you may have received the Comirnaty® vaccine from Pfizer-BioNTech as the first dose and you may have been offered the Spikevax® vaccine from Moderna as the second dose. This is called a series of mixed vaccines.

The National Advisory Committee on Immunization (NACI) recommends getting an mRNA vaccine (Comirnaty® from Pfizer-BioNTech or Spikevax® from Moderna) for your second dose. Find out more about mRNA vaccines

For more information:

1. mRNA vaccines
2. Viral vector vaccines

Vaccine ingredients

Medicinal ingredient

MRNA

Other ingredients

1. 1,2-distearoyl-Sn-glycerol-3-phosphocholine
2. Acetic acid
3. Cholesterol
4. Lipid SM-102
5. Polyethylene glycol (PEG) 2000 DMG
6. Sodium acetate
7. Sucrose
8. Tromethomin
9. Tromethomin hydrochloride
10. Water for injection

This vaccine does not contain common food allergens, such as eggs, shellfish, gluten, or nuts.

Possible side effects

After administration of a vaccine, it is common to have temporary side effects. They usually last a few hours or days after vaccination.

This is the body's natural response to build immunity against disease.

Common side effects of vaccines

Symptoms at the injection site

1. Redness
2. Pain
3. Swelling

Flu-like symptoms

1. Chills
2. Fatigue
3. Joint pain
4. Headache
5. Mild fever
6. Muscle pain

Rare side effects related to vaccination

Here are some rare reactions that have been reported and confirmed after administration of mRNA vaccine:

1. Myocarditis and pericarditis
2. Bell's palsy (facial paralysis)

A severe allergic reaction (anaphylaxis) is also possible, but rare. Signs and symptoms of an anaphylactic reaction to a vaccine include:

1. hives (bumps on the skin that often cause a lot of itching)
2. swelling of the lips, face, tongue, or respiratory tract
3. difficulty breathing
4. an increase in heart rate
5. loss of consciousness
6. a sudden drop in blood pressure
7. abdominal pain, vomiting, and diarrhea

Call emergency services if you have or are witnessing severe symptoms that could be an allergic reaction after vaccination.

Reporting a possible serious reaction

Consult your health care provider if you experience:

1. a side effect after receiving a COVID-19 vaccine
2. any persistent, new, or worsening symptoms

Health care providers should report possible post-vaccination reactions to local public health authorities. They will then report them to the Public Health Agency of Canada.

Summary of this week's report updated November 15, 2021

As of November 5, 2021, 58,739,700 doses of vaccine have been administered in Canada. Adverse events (side effects) were reported by 23,676 people or approximately 4 adverse events reported for every 10,000 people vaccinated.

Of the 23,676 individual reports, 17,777 are considered non-serious (0.030% of all doses administered) and 5,899 are considered serious (0.010% of all doses administered).

Most adverse events are mild and include pain at the injection site or a slight fever.

Serious adverse events are rare but possible. Of these events, anaphylaxis (a severe allergic reaction) was reported 588 times for all COVID-19 vaccines in Canada. This is the reason why you need to wait some time after receiving the vaccine in order to receive treatment in the case of an allergic reaction.

1. All serious side effects are subject to a medical review to determine if there are any safety concerns that require additional measures. As part of these processes, provincial and territorial partners, the regulator, research networks and medical advisors meet regularly to review the data and verify that there are no safety issues requiring action. Unforeseen security issues are detected early and action is taken immediately.
2. The Public Health Agency of Canada (PHAC) and Health Canada continue to closely monitor Canadian and international reports from:

• Thrombosis with thrombocytopenia following immunization with COVID-19 with an AstraZeneca/COVISHIELD Vaxzevria vaccine. Health Canada has updated the product monograph to include information on these very rare events of blood clots associated with low platelet counts following vaccination.
• Guillain-Barré syndrome (GBS) following administration of AstraZeneca/COVISHIELD's Vaxzevria COVID-19 vaccine. Data in Canada have observed a higher rate than expected in the general population. Health Canada has updated the AstraZeneca/COVISHIELD Vaxzevria Vaccine Product Monograph to include information on GBS.
• Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the envelope of the heart) following vaccination with messenger RNA vaccines. Data in Canada now indicates a higher number of reports among youth (under 40 years of age) than would normally be expected in this age group in the general population. Health Canada recently updated the product monographs for Moderna's Spikevax and Pfizer-BioNTech's Comirnaty vaccines to include information on these vaccines. 
• Capillary leak syndrome following vaccination with AstraZeneca/COVISHIELD Vaxzevria vaccine. Health Canada works closely with manufacturers and international regulators to review information as it becomes available and will ensure that manufacturers include the necessary information on product labels as needed. Health Canada has updated the product monograph to include information on capillary leak syndrome, including a contraindication for patients who have previously suffered from this syndrome.
• Facial paralysis (Bell's palsy) following VACCINATION against COVID-19. Health Canada has updated the product monograph for Pfizer-BioNTech's Comirnaty vaccine and Moderna's Spikevax vaccine to include information on Facial palsy/Bell's palsy.

The benefits of vaccines authorized for use in Canada continue to outweigh the risks.